NATIONAL NAL REGUL ULATORY ATORY CONFEREN ERENCE CE 2013 7 – 9 MAY 2013 ISTANA HOTEL KUALA LUMPUR
Pharmacy Legislative Transformation Mohd Zulkifli Abd Latif Deputy Director PH PHAR ARMACY CY EN ENFORCEM CEMEN ENT T DI DIVI VISI SION MINIST STRY Y OF HEAL EALTH TH MAL ALAYSI SIA 9 MAY 2013 @ 11.00am -11.45am ISTANA HOTEL KUALA LUMPUR
Scope of Presentation Pharmacy Legislative: Existing Laws 1. Poisons Act 1952 [Act366] 2. Sale of Drugs Act 1952 [Act368] 3. Medicines (Advertisement and Sale) Act 1956 [Act 290] 4. Registration of Pharmacists Act 1951 [Act 371 ] Constraints in the present Legislations 1. None deterrent penalties 2. Do not accommodate current needs 3. Bureaucratic 4. Limitations on Enforcement Activities 5. Limited access to accommodate International Obligations Proposals in the new “Pharmacy Act 201_?” 1. Merging all 4 existing Acts through Consolidation, Harmonisation, and Liberalisation in the Pharmacy Legislations 2. Address lacunae and loopholes in present legislations 3. Deterrent penalties on serious offences 4. May accommodate current needs through directives 5. Reduce bureaucracy (through directives) 6. Wider scope of coverage in Enforcement Activities 7. At all time may accommodate to current International Requirements
Pharmacy Legislative: Existing Laws 1. Poisons Act 1952 [Act366] Regulating the importation, possession, manufacture, compounding, storage, transport, sale and use of poisons. 2. Sale of Drugs Act 1952 [Act368] Regulating the sale of drugs. 3. Medicines (Advertisement and Sale) Act 1956 [Act 290] Control on advertisements relating to medical matters and to regulate the sale of substances recommended as a medicine. 4. Registration of Pharmacists Act 1951 [Act 371 ] Establishment of a Pharmacy Board and the registration of pharmacists.
Constraints in the present Legislations 1. None deterrent penalties Highest penalty of fine RM25,000 or 3 years imprisonment or both do not deter offenders either to commit or to repeat. Some offences may harm the public and may also cause death eg. Diversion of psychotropic substances and precursor chemicals & adulteration of poisons in traditional medicines and food & beverages. 2. Do not accommodate current needs Changes in current technologies cannot be applied. The need to put certain changes or requirements in the Act may take a long time as it has to go through Parliament 3. Bureaucratic Most amendments has to go through Parliament or through the Minister. Some decisions has to be made by Boards or Authority that meet less frequent. Certain implementations cannot be done immediately. 4. Limitations on Enforcement Activities Restricted enforcement powers that may easily be challenged in Court like power to audit, detain, seal or closure of premises. No provision on accessibility to computer data Most directives are not legally binding 5. Limited access to accommodate International Obligations Most International requirements are done administratively and do not have legal standing.
Proposals in the new “Pharmacy Act 201_?” 1. Merging all 4 existing Acts through Consolidation, Harmonisation, and Liberalisation in the Pharmacy Legislations. 2. Addresses lacunae and loopholes in present legislations. 3. Deterrent penalties on serious offences. 4. May accommodate current needs through directives. 5. Reduce bureaucracy (through directives). 6. Wider scope of coverage in Enforcement Activities. 7. At all time may accommodate to current International Requirements.
Powers of Minister of Health • Appointment of Members of Pharmacy Council • Make Regulations • Make Schedules Classification of Medicines/Medicinal Substances Prohibited Substances Fees for Registrations and licenses Controlled Substances/Products • Consider Appeals • Giving Exemptions (* with advise of Competent Authority) 7
Establishment of Pharmacy Council Senior r Dire rector r of Pharm rmaceutical Serv rvices as the Chairm rman of the Pharm rmacy • Council. Consisti ting 16 members rs (8 pharm rmacists ts in Public Secto tor, r, 3 academicians, , 2 • industri trial pharm rmacists ts, , 3 private pharm rmacists ts [1 Semanjung,1 ,1 Sabah and 1 Sara rawak wak] ] ). Retention of pharmacists registration and disciplinary action. Start registering pharmacy assistant s Involving more than 6,000 pharmacy assistants More than 50% serving MOH Maintain the quality of diploma graduates from 29 private institutions 8
Powers of Competent Authority (CA) [Senior Director of Pharmaceutical Services as The Competent Authority] • CA may delegate powers to Officers in Pharmaceutical Services for purpose of carrying into effect the provisions of the Act. NEW CONTROL ON MEDICINES • Classification and registration of medicinal products on the advise of Evaluation Committee LICENCES Registration on all pharmacy premises • New license for Clinical Trial • New license for professionals and industries 9
EVALUAT UATIO ION COMITTE TE The Committ ittee assist sts s the CA for purpose se of classifica ssificatio tion of medici icinal l products cts & substa stance ce , registr istration ion of medicina cinal l products cts and evalu luate medicin cinal l claim ims s befo fore re regist strat ratio ion. A Pharmac acis ist in Public lic Sector or appoint inted ed by CA to be the Chairm irman an 21 permane anent nt member ers which consist t of fully registere tered d pharma macists ts in • the public service. e. 6 a associate te member ers • With th relevant t experti rtise; specialist t qualifi ficati tion or experi rience in medicine, , pharm rmaceuti tical sciences or vete teri rinary ry medicine which consist t of at least t a fully registere red pharm rmacist t in the private te secto tor r specializing in manufa factu turi ring of products ts, a toxicologist t and registe tere red vete teri rinary ry surg rgeon 10
Harmonisat onisation ion of Produc uct Class assif ific ication ation New Pharma macy Law Present nt Law : First Schedu dule 3 C Classificati tion ons of Medicina nal Part I Poison • Produc ucts ts (Grou oup A, B B, C & & D D P Poisons ns ) Part II Poisons ns • 1. 1. Prescripti tion on Only Medicine ne Second nd Schedul ule e 2. 2. Pharma macist t Only Medicina nal Non Poison on • Produc uct Third d Schedu dule 3. 3. General al Sale List Psycho hotr tropi pic Substan ances es • 11
1. Prescri ripti tion Only Medicine: – Registe tere red psychotro tropic medicine – Registe tere red Narcoti tic Medicine – Registe tere red Medicine (Group B Poison under r the present t Poisons Act t 1952) 2. Substa tance/Ph Pharm rmacy Only Medicinal Product Acti tive Substa tance of Psychotro tropic/Pre /Precurs rsors rs (Pre reviously Group B or C) C) Pharm rmacy Only Medicinal Product t – available from a registe tere red pharm rmacist t with thout t a prescri ripti tion - (Pre reviously Group C) C) ( finished product t to be dispensed conta taining anti tihista tamine, , pholcodeine, , anti tidiabeti tic, , exte tern rnal prepara rations containing anti tibioti tic/s /ste tero roid ) 3. Genera ral Sale List :- – Industri trial usage for precurs rsor r substa tance, acid and alkali solvents ts – Registe tere red products like traditi tional prepara rati tions, supplements ts or noti tifi fied cosmeti tic s available over-th the-counte ter . 12
Harmoni nisati tion on on Licens nses es New Pharmacy cy Law Prese sent t Law : Licens nses es for wholesale / CA issues Licenses for manufactur acture/i /imp mport ort issued ed by Wholesale, , Import, rt, Manufacture re and Clinical PKPF PKPF Trial for r Medicinal Type e A,B,C,D, D,E Licens nses es Products. . issue ued d by State Licens nsing ng Officer er Power r can be delegate ted to the respecti tive State te Deputy ty Directo tor r of Health th (Pharm rmacy) 13
Harmoni nisati tion on on the Control ol of Precursors rsors Prese sent t Law : New Pharmacy cy Law No contro rol on the brokers rs of Broker r license precurs rsor r substa tances User r License for Prevent the Country try as transit t Industri tries/Com /Commerc rcial point t for precurs rsors rs End-user r Declara rati tion Advantage for the country try as hub for r development of pharm rmaceuti tical industry try) 14
Interrelationship of methamphetamine and main precursor substances Interrelationship Cl O H Benzylchloride O N Methylformamide Leuckart method ( Formic acid ) N N-formylmethamphetamine BMK (P-2-P) Methylamine, Aluminum, Benzylcyanide Mercuric chloride AA (acetic anhydride), Hydrochloric acid Reductive amination Natrium acetate anhydride OH O Phenylacetic acid OH H Lithium (or Natrium) in Liquid ammonia H N N Birch reduction O Hydriodic acid, Red phosphorus H Nagai method Methamphetamine Ephedrine Perchloric acid, Hydrogen gas, Palladium-Bariumsulfate Benzaldehyde Rosenmund method Hydrogen gas, Thionyl chloride Palladium-Bariumsulfate Cl H N Emde method Chloroephedrine
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